Archives: Agenda

• How to align CDMO partnerships with phase-specific needs while staying agile
• How to collaborate across CDMOs and ensure smooth tech transitions, especially for biologics therapies
• How to build transparent CDMO partnerships from Day 1 to overcome challenges and save costs

• Aligning Manufacturing, Regulatory, and Clinical Operations to eliminate silos and enable integrated, compliant decision-making
• Establishing governance and ownership frameworks linking supply execution with financial planning to drive transparency, accountability, and aligned decisions
• Identifying and resolving end-to-end process bottlenecks to improve agility, reduce risk, and ensure supply continuity across clinical and commercial programs

• How to use predictive modelling to identify supply risks before they impact the investigator site to maintain your clinical on time delivery
• How to leverage “Track and Trace” platforms to confirm shipment integrity and temperature excursions in minutes, not days!
• How AI agents are streamlining label translations and regulatory paperwork to keep global trials moving at pace

IQVIA

• Managing regulatory, operational, and cultural considerations for successful site activation: Outsourcing for global submissions
• Insights into emerging geographies and how to navigate varying cultural landscapes
• Diving into the practical realities of managing multiple vendors, with strategies for maintaining consistency and compliance across borders
• Strategies for sponsors to optimize patient recruitment, site engagement, and trial efficiency in evolving clinical landscapes

Presented by Emmaus Life Sciences

• Bringing the patient voice into every stage of development and embedding patient advocates from day one, moving from feedback to true co-creation across the trial lifecycle
• Breaking down barriers in access, diversity, and language to expand participation, build trust, and make trials truly patient-centered
• Simplifying participation and communication to reduce burden, improve understanding, and generate richer, more meaningful data
• Leveraging patient experiences to help change the landscape, making clinical trials better for patients worldwide

As insurers face mounting operational and demographic pressures, we explore whether agentic AI can move beyond hype to become the industry’s next true transformation layer.